A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.

November 14, 2012 updated by: AstraZeneca

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Active Controlled, Parallel Group, Multicenter Study to Assess the Safety and Efficacy of 2 Fixed Dose Groups of TC-5214 (S-mecamylamine) as Monotherapy Treatment in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

The purpose of this study is to assess the safety and effect of TC-5214 as a single therapy in patients with major depressive disorder who exhibit inadequate response to antidepressants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
145

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tallin, Estonia
        • Research Site
      • Tallinn, Estonia
        • Research Site
      • Tartu, Estonia
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Jyväskylä, Finland
        • Research Site
      • Kuopio, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
  • India
      • Kanpur, India
        • Research Site
      • Pune, India
        • Research Site
    • Andh Prad
      • Visakhapatnam, Andh Prad, India
        • Research Site
    • Gujarat
      • Ahmedabad, Gujarat, India
        • Research Site
    • Kamataka
      • Bangalore, Kamataka, India
        • Research Site
    • Karnataka
      • Bangalore, Karnataka, India
        • Research Site
      • Mangalore, Karnataka, India
        • Research Site
    • Mahara
      • Nashik, Mahara, India
        • Research Site
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Research Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India
        • Research Site
    • Uttar Prad
      • Varanasi, Uttar Prad, India
        • Research Site
  • Japan
      • Kumamoto, Japan
        • Research Site
    • Aichi
      • Nagoya, Aichi, Japan
        • Research Site
    • Chiba
      • Ichikawa, Chiba, Japan
        • Research Site
      • Noda City, Chiba, Japan
        • Research Site
    • Fukuoka
      • Fukuoka-city, Fukuoka, Japan
        • Research Site
      • Omuta-City, Fukuoka, Japan
        • Research Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Research Site
      • Sapporo-shi, Hokkaido, Japan
        • Research Site
      • Sapproro, Hokkaido, Japan
        • Research Site
    • Hyogo
      • Akashi, Hyogo, Japan
        • Research Site
      • Kobe, Hyogo, Japan
        • Research Site
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan
        • Research Site
      • Sagamihara-shi, Kanagawa, Japan
        • Research Site
      • Yokohama-city, Kanagawa, Japan
        • Research Site
      • Yokohama-shi, Kanagawa, Japan
        • Research Site
    • Kumamoto
      • Yatsushiro, Kumamoto, Japan
        • Research Site
      • Yatsushiro-city, Kumamoto, Japan
        • Research Site
    • Kyoto
      • Ukyo-ku ,Kyoto, Kyoto, Japan
        • Research Site
    • Okayama
      • Kurashiki-shi, Okayama, Japan
        • Research Site
    • Tokyo
      • Kodaira-shi, Tokyo, Japan
        • Research Site
      • Meguro-ku, Tokyo, Japan
        • Research Site
      • Minato-ku, Tokyo, Japan
        • Research Site
      • Setagaya-ku, Tokyo, Japan
        • Research Site
      • Shinagawa-ku, Tokyo, Japan
        • Research Site
  • United States
    • California
      • Beverly Hills, California, United States
        • Research Site
      • Chino, California, United States
        • Research Site
      • Garden Grove, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • Torrance, California, United States
        • Research Site
    • Florida
      • Bradenton, Florida, United States
        • Research Site
      • Coral Springs, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • North Miami, Florida, United States
        • Research Site
      • St Petersburg, Florida, United States
        • Research Site
      • West Palm Beach, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
    • Illinois
      • Joliet, Illinois, United States
        • Research Site
    • Kansas
      • Prairie Village, Kansas, United States
        • Research Site
    • Mississippi
      • Flowood, Mississippi, United States
        • Research Site
    • New York
      • New York, New York, United States
        • Research Site
      • Rochester, New York, United States
        • Research Site
    • Ohio
      • Dayton, Ohio, United States
        • Research Site
      • Mason, Ohio, United States
        • Research Site
    • Oregon
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • Research Site
    • Texas
      • Dallas, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
    • Washington
      • Seattle, Washington, United States
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of signed and dated informed consent before initiation of any study-related procedures.
  • The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
  • Women of child-bearing potential must have a negative urine pregnancy test and confirmed use of a highly effective form of birth control before enrollment and until 3 months after their last dose of study drug.
  • Outpatient status at enrollment and randomization.

Exclusion Criteria:

  • Patients with a lifetime history of bipolar disorder; psychotic disorder or post-traumatic stress disorder.
  • Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide.
  • Patients with any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.
  • History of stroke or transient ischemic attack, seizures or seizure disorder, head trauma including closed head injury.
  • Pregnancy or lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: 4
Placebo
Drug: Placebo
Tablet, oral, twice daily for 8 weeks
Experimental: 1
TC-5214, 1 mg BID
Drug: TC-5214
Tablet, oral, twice daily for 8 weeks
Experimental: 2
TC-5214, 4 mg BID
Drug: TC-5214
Tablet, oral, twice daily for 8 weeks
Active Comparator: 3
Duloxetine 60 mg Q Day
Drug: Duloxetine
Capsule, oral, once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment
Time Frame: Randomization (Week 8) to end of treatment (Week 16)
A 10-item scale for the evaluation of depressive symptoms. Each Montgomery Asberg Depression Rating Scale (MADRS) item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Randomization (Week 8) to end of treatment (Week 16)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hans A Eriksson, MD, PhD, MBA, AstraZeneca R&D Södertälje

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D4131C00001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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